QAU · Class II · 21 CFR 878.4456

FDA Product Code QAU: Hemostatic Device For Endoscopic Gastrointestinal Use

Hemostatic Device For Intraluminal Gastrointestinal Use. A Hemostatic Device For Intraluminal Gastrointestinal Use Is A Prescription Device That Is Endoscopically Applied To The Upper And/or Lower Gastrointestinal Tract And Is Intended To Produce Hemostasis Via Absorption Of Fluid Or By Other Physical Means.

Leading manufacturers include Wilson-Cook Medical, Inc., 3-D Matrix, Inc. and Nextbiomedical Co., Ltd..

12
Total
11
Cleared
261d
Avg days
2018
Since
Growing category - 5 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 136d recently vs 350d historically

FDA 510(k) Cleared Hemostatic Device For Endoscopic Gastrointestinal Use Devices (Product Code QAU)

12 devices
1–12 of 12
Cleared Aug 03, 2026
PuraStat GI
K261503
3-D Matrix, Inc.
General & Plastic Surgery · 89d
Cleared Jun 02, 2026
Hemospray Endoscopic Hemostat (HEMO-[X])
K253302
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 246d
Cleared Jan 07, 2026
PuraStat
K253924
3-D Matrix Europe SAS
General & Plastic Surgery · 30d
Cleared Nov 27, 2024
Nexpowder
K240994
Nextbiomedical Co., Ltd.
General & Plastic Surgery · 230d
Cleared Oct 22, 2024
PuraStat
K242250
3-D Matrix Europe SAS
General & Plastic Surgery · 83d
Cleared Jul 26, 2024
Resolv Endoscopic Hemostat System
K234131
Hemostasis, LLC
General & Plastic Surgery · 211d
Cleared Feb 28, 2023
PuraStat
K222481
3-D Matrix, Inc.
General & Plastic Surgery · 195d
Cleared Sep 16, 2022
Nexpowder
K202929
Nextbiomedical Co., Ltd.
General & Plastic Surgery · 717d
Cleared Jun 25, 2021
PuraStat-GI
K210098
3-D Matrix, Inc.
General & Plastic Surgery · 162d
Cleared Jan 29, 2021
EndoClot
K190677
Endoclot Plus Co., Ltd.
General & Plastic Surgery · 686d
Cleared Jun 10, 2020
Hemospray Endoscopic Hemostat
K200972
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 58d
Not Cleared May 07, 2018
Hemospray Endoscopic Hemostat
DEN170015
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 424d

About Product Code QAU - Regulatory Context

510(k) Submission Activity

12 total 510(k) submissions under product code QAU since 2018, with 11 receiving FDA clearance (average review time: 261 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QAU Product Code

Recent submissions under QAU have taken an average of 136 days to reach a decision - down from 350 days historically, suggesting improved FDA processing for this classification.

QAU devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →